The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the press release, Banyan BTI is...more

The inclusion of a non-compete agreement, or covenant not to compete, is frequently one of the most anxiety-producing issues in physician employment contracting on the part of both the physician and the employer. This has...more

At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their...more

Complex. Hard. Humbling. These are the descriptors former Google CEO Eric Schmidt used last week at the HIMSS 2018 Annual Conference in Las Vegas to describe the work to be done in health information technology (HIT). ...more

The recently released Protenus Healthcare Breach Barometer report notes that in January, 2018, at least 473,807 patient records were compromised in 37 breaches reported to the Office for Civil Rights. ...more

Some recent changes in federal law and in federal agency interpretation of federal law may both clarify and relieve some regulatory obligations of health care providers.
Lessening Dependence on Federal Agency...more

Stephen Hawking may have been the smartest guy in the world, even though he believed that “People who boast about their I.Q. are losers.” Hawking is best known for his work on black holes. As used in physics, a black hole...more

The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference focuses on investing in surgical specialty practices.
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Investment and...more

In a watershed case, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) unwound key components of the controversial 2015 ruling by the Federal Communications Commission (FCC or Commission)...more

We invite you to view Employment Law This Week® - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held...more

The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.” What was the...more

In February, the Department of Justice (DOJ) intervened in a False Claims Act case alleging healthcare fraud, a common enough event.
The case in question, originally began in 2015 as a whistleblower case brought by two...more

Recently, Cigna announced its plan to purchase pharmacy benefit manager (“PBM”) Express Scripts. In a March 14, 2018 letter to the chair of the House Committee on Energy and Commerce, Gregory Walden (R-Oregon), Congressman...more

The Department of Justice (DOJ) recently resolved two health care fraud cases – one criminal and one civil – that demonstrate the government’s continued scrutiny of lavish meals and “speaker’s bureaus” sponsored by...more

Alabama Data Breach Notification Act -
On March 1, 2018, the Alabama Senate voted for passage of Senate Bill 318,the Alabama Data Breach Notification Act, by a vote of 24-0. The bill is now being considered by the Alabama...more

On February 22, 2018, the Centers for Medicare & Medicaid Services (CMS) released several new and revised provider compliance tip sheets as part of its monthly update to the Medicare Learning Network (MLN) homepage....more

The Pennsylvania Department of Health (DOH) published the much anticipated final version of the temporary regulations under the Medical Marijuana Act applicable to Clinical Registrants and Academic Clinical Research Centers...more

In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders....more

Holders of Florida healthcare clinic license exemptions take note. Exemption certificates, which currently bear no expiration date, will expire every two years if a bill recently passed by the Florida Legislature becomes law....more

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